UVADEX Solution for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Therakos, Inc.

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BOXED WARNING SECTION

<b>UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience ...

1. Description

Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins. The chemical ...

2. Clinical Pharmacology

Mechanism of action The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent ...

3. Indications and Usage

UVADEX (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell ...

4. Contraindications

UVADEX (methoxsalen) Sterile Solution is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds or any of the excipients. Patients possessing ...

5. Warnings

Concomitant Therapy Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, ...

6. Precautions

Patients with Renal or Hepatic Impairment UVADEX has not been evaluated in patients with renal or hepatic impairment. Renal impairment Although renal transplant recipients with poor renal function have ...

6.1. General

Actinic degeneration After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in premature aging of the skin. Basal cell carcinomas Since oral psoralens may increase ...

6.2. Information for Patients

Patients should be told emphatically to wear UVA-absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SP 15 or higher) for the twenty-four (24) hour period following treatment with ...

6.4. Drug Interactions

See Warnings Section.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

See Warnings Section.

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methoxsalen is administered to a nursing woman.

6.10. Pediatric Use

Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the Warnings Section as well as the ...

7. Adverse Reactions

Side effects of photopheresis (UVADEX used with THERAKOS Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%). In study CTCL 3 (UVADEX), six ...

9. Overdosage

In the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.

10. Dosage and Administration

Each UVADEX treatment involves collection of leukocytes, photoactivation, and reinfusion of photoactivated cells. UVADEX (methoxsalen) Sterile Solution is supplied in 10 mL vials containing 200 mcg of ...

11. How Supplied

UVADEX (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL amber glass vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). One vial of 10 mL contains 200 micrograms methoxsalen. Manufactured ...

12. Storage and Handling section

The drug product must be stored between 59°F (15°C) and 86°F (30°C).

13. Clinical Studies

Three single-arm studies were performed to evaluate the effectiveness of photopheresis in the treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL). In the first study (CTCL 1), 39 patients ...

14. References

Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. ...